Clinical Trail to evaluate the efficacy and safety of Vestige Flax Oil capsules in patients suffering from Dyslipidemia

Phase 4

Completed

• Conditions: Health Condition 1: E785- Hyperlipidemia, unspecified

• Registration Number: CTRI/2022/09/045325
• Lead Sponsor: Vestige Marketing Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-06-26
• Last Update Posted: 16 October 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1.Subject is willing and able to give written informed consent.

2.Female subjects aged = 18 and = 65 years

3.The subjects will be considered to have dyslipidemia if they met 2 of the following 4 criteria:

•fasting total cholesterol concentration >200 mg/dL,

•fasting triglyceride concentration >150mg/dL,

•fasting LDL-cholesterol concentrations >100 mg/dL, or

•fasting HDL-cholesterol concentrations >40 mg/dL.

4.Patients who are taking lipid lowering drugs should continue the same dosage during the study.

5.Subject is willing, able, and likely to comply with all study procedures and restrictions.

Exclusion Criteria

1.Subjects with history of CVD or other severe chronic disease or use of any drugs known to affect lipid metabolism.

2.Subjects who have used any antioxidant such as Vitamin E, vitamin C, Phytochemicals, and coenzyme Q10 within two months before trial.

3.Pregnant or lactating women

4.Patients with Homozygous Familial Hypercholesterolemia

5.AST or ALT level increases at least twice the upper limits of normal in patients

6.Subjects who had an administration of other investigational product or medical device for clinical trial 4 weeks prior to participation of clinical trial.

7.Any other condition that in the investigator’s judgment might interfere with study objectives.

Study & Design

• Study Type: Interventional
• Study Design: Not specified